Kerr Director, Manufacturing Process Development (Pomona, CA)

Primary Duties & Responsibilities

• Develop process development strategy and roadmaps aligned to business and portfolio priorities, setting standards, governance, and resourcing for development, scale-up, validation, and lifecycle support.
• Lead, coach, and develop a process engineering team, building technical depth, accountability, and succession planning.
• Develop scalable manufacturing platforms, standards, and reusable process technologies to accelerate future product introductions and operational excellence.
• Drive development and adoption of innovative manufacturing technologies and automation solutions to improve scalability, quality, efficiency, and competitive advantage.
• Partner with product development teams to embed design-for-manufacturability principles early in product and formulation development.
• Own process development from feasibility through validation and transfer for adhesives, composites, cements, endodontic, and other dental consumable platforms, defining process specifications, critical parameters, and controls.
• In collaboration with Chemistry team, characterize material and process behavior (e.g., rheology, mixing, variability, hold times) to build scientific understanding linking materials, equipment, and finished-product performance.
• Apply Design of Experiments (DOE), statistical analysis, and risk-based tools to define process design spaces, control strategies, and acceptance criteria.
• Identify, assess, and mitigate manufacturing, scale-up, and commercialization risks throughout the product lifecycle.
• Lead pilot builds, scale-up, qualification, validation, and manufacturing transfer, ensuring readiness criteria, documentation, and training are in place.
• Provide process development leadership on New Product Development (NPD), commercialization, and lifecycle teams, aligning scope, risk, resources, and timelines across functions.
• Serve as the key technical liaison between Manufacturing and R&D, building trust and alignment across functions without relying on positional authority.
• Partner with Operations and Engineering to optimize processes, troubleshoot issues, and improve capability across the product lifecycle, clarifying handoffs from development to routine manufacturing.
• Collaborate on investigations into nonconformances, deviations, and quality events using root-cause analysis and statistical methods to drive effective CAPAs.
• Define equipment and process requirements and partner with cross-functional teams and vendors on selection, integration, and automation to improve safety, quality, and efficiency.
• Drive measurable improvements in yield, throughput, cycle time, capability, and cost through continuous improvement initiatives.
• Ensure all activities comply with the Quality Management System (QMS), FDA requirements, ISO 13485, GMP, EH&S, and applicable SOPs; support audits, CAPAs, and regulatory submissions.
• Communicate strategy, readiness, risk, and outcomes to senior leadership, ensuring sound documentation and escalation practices.
• Travel approximately 25% domestically and internationally to support manufacturing sites.

Qualifications

• Bachelor’s degree in Chemical Engineering, Materials Science, Polymer Science, Chemistry, Biomedical Engineering, Manufacturing Engineering, or a related discipline required; master’s degree or PhD preferred.
• 10+ years of progressive experience across developing, scaling, or validating manufacturing processes in a regulated or formal quality-system environment is required.
• 5+ years of people and cross-functional leadership experience required.
• Experience in supporting multi-site or global manufacturing operations preferred.
• Experience with Lean manufacturing or Six Sigma tools and/or methodologies required.
• Demonstrated ability to influence without authority, gain commitment, and lead through relationships, technical credibility, data, and shared business objectives required.
• Exceptional relationship-building and collaboration skills, with a demonstrated ability to create alignment and trust between Manufacturing and R&D required.
• Strong people leadership skills with a record of developing technical talent, building capability, setting clear expectations, and driving accountability required.
• Advanced problem-solving and analytical skills, including Design of Experiments (DOE), statistical analysis, process capability, root-cause analysis, and risk-based decision making required.
• Demonstrated ability to lead complex programs, prioritize resources, manage ambiguity, resolve conflict, and drive execution across functions and sites required.
• Strong business and operational acumen, including the ability to balance safety, quality, compliance, delivery, innovation, capacity, and cost required.
• Strong verbal, presentation, facilitation, and technical writing skills in English, with the ability to communicate effectively from the manufacturing floor through executive leadership required.
• Experience working with formulated medical-device products preferred.
• Ability to build business cases and use data to support equipment, automation, process technology, capacity, and cost-improvement investments preferred.
• Intermediate Microsoft Office skills, including Outlook, Word, Excel, and PowerPoint, required; proficiency with statistical analysis software and aptitude to learn enterprise systems preferred.